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Flourish Vaginal Care System for Neovaginal Microbiome Health

N/A
Waitlist Available
Led By Christine McGinn, DO
Research Sponsored by Sexual Health and Wellness Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy cisgender women ages 18-52
Transgender women over age 18 who are preparing to undergo gender-confirmation surgery
Must not have
Immunosuppressed
Known (neo)vaginal infection that is not yeast or BV at start of protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collections at time 0, 6 weeks, and 6 months
Awards & highlights

Summary

This trial looks at whether a vaginal wellness system can help establish a microbiome in transgender women.

Who is the study for?
This trial is for healthy cisgender women aged 18-52 and transgender women over age 18 who are planning to have gender-confirmation surgery. Participants should not be allergic to aloe vera or components of the Flourish Vaginal Care system, nor have certain infections or immune suppression.Check my eligibility
What is being tested?
The study is testing the Flourish Vaginal Care System's ability to establish a healthy microbiome in neovaginas of transgender women post-surgery, using commercially-available wellness products.See study design
What are the potential side effects?
Potential side effects may include reactions related to sensitivities or allergies to ingredients in the vaginal care products such as aloe vera. Specific side effects will depend on individual tolerances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a healthy woman aged 18-52.
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I am a transgender woman over 18 planning for gender-confirmation surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My immune system is weakened.
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I have a vaginal infection that is not yeast or BV.
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I cannot tolerate Restore gel after my surgery.
Select...
I am not allergic to aloe vera or ingredients in Restore®, Balance, or BiopHresh®.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collections at time 0, 6 weeks, and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and collections at time 0, 6 weeks, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vaginal microbiome
Vaginal pH
Secondary outcome measures
VSQ

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Group 3: Cisgender womenExperimental Treatment1 Intervention
This group will use the Flourish Vaginal Care system for 6 months: Balance external wash daily; Restore intravaginal gel every other day at bedtime; BiopHresh homeopathic/probiotic suppository every 3rd day at bedtime through the end of study.
Group II: Group 1: Transgender women using FlourishExperimental Treatment1 Intervention
After gender-confirming surgery, this group will use the Flourish Vaginal Care System for six months, ramping up usage with healing. They will use "Balance" external wash beginning day 6 after surgery; "Restore®" vaginal moisturizing gel on dilators beginning day 6 after surgery; Restore every other day at bedtime with "BiopHresh" homeopathic/probiotic suppository every 3rd day at bedtime beginning week 6 after surgery through end of study at 6 months.
Group III: Group 2: Transgender women not using FlourishActive Control1 Intervention
After gender-confirming surgery, this group will use only KY jelly on dilators beginning day 6 after surgery according to routine care; they will use any standard hygiene product (soap, body wash, etc) of their choice except products used by Group 1 through the end of the study at 6 months.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Treatments aimed at establishing a healthy neovaginal microbiome, such as the Vaginal Wellness System, often involve the use of probiotics and prebiotics. Probiotics introduce beneficial bacteria to the vaginal environment, helping to outcompete harmful pathogens and restore microbial balance. Prebiotics provide nutrients that support the growth of these beneficial bacteria. This is important for neovaginal microbiome patients as a balanced microbiome can prevent infections, reduce inflammation, and improve overall vaginal health.

Find a Location

Who is running the clinical trial?

Sexual Health and Wellness InstituteLead Sponsor
8 Previous Clinical Trials
114 Total Patients Enrolled
Vaginal Biome ScienceLead Sponsor
8 Previous Clinical Trials
114 Total Patients Enrolled
Papillon CenterUNKNOWN

Media Library

Flourish Vaginal Care system (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05372770 — N/A
Neovaginal Microbiome Research Study Groups: Group 1: Transgender women using Flourish, Group 2: Transgender women not using Flourish, Group 3: Cisgender women
Neovaginal Microbiome Clinical Trial 2023: Flourish Vaginal Care system Highlights & Side Effects. Trial Name: NCT05372770 — N/A
Flourish Vaginal Care system (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05372770 — N/A
~17 spots leftby Jul 2025